A new procedure is a (usually) physical procedure on 1 single person who is consenting. If it goes wrong only 1 person is harmed (or not improving at least)A new drug is something (bio)chemical of which the long term implications are more difficult to oversee. Aspirin is with us now since 1860 or so and still we find out new benefits and drawbacks of it. Further still, it is to be given as a treatment to a much larger set of individuals, so the potential harm done is therefore greater and thus needs more and rigorous testing before it can be deployed.So I think (although I am not at all a medic) that therefore the consent of only the patient is enough if the applicable law's and Hipocratic oath is not broken in such matters.

The FDA is just an arm of the pharmaceutical companies. The majority of the people that work at the FDA either worked for the companies they regulate in the past, or will work for them after they leave the FDA. Just like most of the branches of our federal government they are corrupt through and through. Could they regulate effectively? Sure! Do they? no. Why don't they regulate "Supplements"? Why do they regulate so many rudimentary anti-inflammatory drugs that have no addictive properties at all? Why can I get enough Tylenol at a gas station to kill 10 people but my asthma inhaler I need a prescription for? Because the FDAs primary role is NOT to keep us safe. It's to keep the drug companies products scarce and drive up their price.

The majority of the people that work at the FDA either worked for the companies they regulate in the past, or will work for them after they leave the FDA

Well, if I were running a drug comapny I would want someone who knows the ins and outs of the bureaucracy, and if I were running a regulatory agency I'd want to hire someone who knows the ins and outs of the industry.

Why don't they regulate "Supplements"?

Because the law doesn't allow them to. That's not the FDA's fault, that's your legislator's fault.

Why do they regulate so many rudimentary anti-inflammatory drugs that have no addictive properties at all?

Because too much aspirin or too much Naproxin Sodium can eat a hole in your intestine wall, and too much acetominaphin (which I don't know how to spell) can ruin your liver. A better question is why they're not regulating addictive drugs like alcohol and tobacco. Of course the reason is because they're regulated by the ATF (which I think should be abolished).

Why can I get enough Tylenol at a gas station to kill 10 people but my asthma inhaler I need a prescription for?

Because the asthma inhaler has steroids, and steroids can do a LOT of things to really fuck you up real good; for instance, steroid eyedrops will give you cataracts (I found this out when I was prescribed them for an eye infection and wound up getting cataract surgery in that eye as a result; it was the eye doctor that told me the steroids caused the cataract).

Get rid of the FDA and you're going to see a hell of a lot more worthless snake oil on the market, which is why the FDA was started in the first place.

Seek medical attention right away if any of these SEVERE side effects occur when using Albuterol:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; ear pain; fast or irregular heartbeat; new or worsened trouble breathing; poundin

I can see why steroids require a prescription (my grandfather died in his 40's because he was over medicated with cortisone). But the warnings for albuterol sound pretty much like the warnings for any OTC medication, and they're considered rare side effects, only listed to cover their asses.

I am not on any bandwagon. The above was just reasoning in a (I think) logical line. Of course the FDA has it's drawbacks and so does the NHF or any other system like it. Because it is a system. No system is without its errors.I have some acquaintances that are physicians of some sort and this is the sort of line of thought I usually hear. So I thought that my answer would be sufficiently on-topic to answer the Parent.

Given how few drugs are meant to save lives, and most are just to make conditions bearable or alleviate temporary effects (and in most cases just to fix patient negligence that cause things like diabetes) I think more people would die due to lack of drug testing than from lack of the drugs in question.

Between this, the latest reports of restoring sigh with implantable photo voltaic chips and engineered nano particle drug delivery, medical science fiction is running out of subjects that are still fiction. Kurzweil's Singularity is looking more and more likely every day.

I'm starting to get the impression that the changes associated with this singularity, while certainly amazing, are not necessarily going to be psychologically comfortable for us flesh bags. I mean, this stuff is only the beginning. Are future software beings going to look pitifully on us because we're traumatized from our world changing underneath us so many times?

medical science fiction is running out of subjects that are still fiction

Indeed, compared to a modern hospital, Dr. McCoy's sick bay looks downright primitive (I journaled [slashdot.org] about this a few years ago). Some things are beyond sci-fi today. For example, in Star Trek II, McCoy gives Kirk reading glasses because he's allergic to lens softeners (we still don't have that) but a CrystaLens implant will cure age related presbyopia, as well as myopia, astigatism, and cataracts -- bus they still haven't invented them

Pretty amazing surgery, but watching the videos shows limited restoration of function. The key is getting the transplanted/regenerating nerves to make the proper connections. The surgery is not going to re-wire the incredible number of connections made during development. Neural prostheses currently offer better dexterity and restoration of function than the nerve transplant. However, it is likely only a matter of time (maybe sever decades) before the neural re-wiring problem is solved.

Don't forget: the nerves they connected the hand to were not meant to be used for this. They wired an "arm up and down" nerve to a "close and open hand" nerve. The brain can adapt and send the new data, but this takes time. Imagine the weirdness when you want to close your hand and had to lift your arm to send that signal. Now you need to learn you should only use one of the muscles involved in lifting your arm, because otherwise you'll lift your arm.

Conversely the brain's body map is actually incredibly malleable anyway - since it expands and contracts to deal with tools you're using and transitioning to or from. People wince when they scrape their car, because in a very real sense they feel like they hit a part of themselves.

With time (and well, it's definitely a permanent part of him) I suspect he could recover full function to the point of not needing to think about it.

People wince when they scrape their car, because in a very real sense they feel like they hit a part of themselves.

Bullshit. People wince when they scrape their cars because its resale value just dropped. You don't wince when you drop your screwdriver and it was part of your hand ten seconds earlier. You might wince if it breaks and you have to buy a new one. Nobody driving a beater cares if it gets another dent. Anyone whose identity depends on their car should be treated by a mental health professional, b

People wince when they scrape their car, because in a very real sense they feel like they hit a part of themselves.Bullshit. People wince when they scrape their cars because its resale value just dropped. You don't wince when you drop your screwdriver and it was part of your hand ten seconds earlier. You might wince if it breaks and you have to buy a new one. Nobody driving a beater cares if it gets another dent. Anyone whose identity depends on their car should be treated by a mental health professional, because that's just fucking crazy.

Well gee, you sure showed the body of neuroscience.

Take a computer then, because the same phenomenon applies: the reason you can use a mouse proficiently is because of exactly the same process. For the duration your holding and interacting via mouse, as far as your brain is concerned it's actually an extension of your body - it's why you don't need to plan how you're going to move your hand to get the cursor somewhere.

Your screwdriver example doesn't apply, because like you said - you dropped it. It was dis

You have to remember that this operation probably caused nerve damage too and nerves take a ridiculously long time to heal (about 6mm per week) also the dude hasn't used his hand in four years so he has probably just forgotten how to use it too. He will have a lot of rehab ahead of him i imagine.

It's far too early to already conclude that reqained functionality is minimal or not worth the risk.

The human nerve system could be compared to the central phone systems of a long time ago where you had an operator that would connect you (where your line inserted) to where you wanted to go by just replugging your cable.

The human or animal body does much the same. It will check what the connections are, and over time optimise them or redirect them if their function has changed.

"The brain has to be trained to think, 'OK, I used to bend my elbow with this nerve, and now I use it to pinch' [...] it's more of a mental game that patients have to play with themselves."

I love imagining just how this would feel. Does the wiring ever become automatic and abstract in the same way that we normally come to experience motor movements(not thinking about pulling this muscle, relaxing that one, but just that we want to move our leg)? Or will he for the rest of his life feel like he is trying to move a specific forearm muscle group when he scratches his head?

When I had my cranial surgery (due to my locked jaw -- had to open my jaw -- it was so bad that I couldn't stick my tongue out), the doctors had to break some nerves to fix this (from my neck and right side of my head near the ear area).

After the complex surgery, the right side of my face were unresponsive (i.e. couldn't move and feel). That included my right eye where I couldn't move my eye lids (not even close fully).

After about two months, I went to another surgery to fix these damaged facial nerves. The doctors fixed this by connecting working nerves to the damaged ones. Basically, they were rerouting these signals as if you were rerouting a network.

Some of my broken nerves are currently recovered, but it will take years to recovered almost fully (not 100%).

5/15/2012: Nope, they never recovered fully. I still can't close my right eye lid fully and can feel a little more, but still can't move fully. The feelings still funky in other areas on my head/face/neck. Heh!

I wonder how much has improved from 1998 if I had that nerve reconstruction in 2010s.

This would be a good candidate for cloning. i.e. clone the nerves. They don't remotely look like body parts so the average person wouldn't be so squeamish about it, and it provides enormous benefit so the public conceivably would back the research. And... it would give scientists the room to figure out how to clone other body parts in immune system agnostic ways for when people would buy into growing a new foot.

Of course obtaining nerves is a problem. To get them you have to take them from somewhere else. They have to disable one part of your body by removing a nerve connection to use it at another point. Granted the ability to walk is more important for most people than being able to say move your arm normally. But why should we have to compromise? I can tell you from experience that having one part of your body, even part of a limb not working right sucks like hell. And cloning removes the problem of rejection.

I knew a guy who tempted fate and jumped into a swimming hole from a railway bridge. It was only about 20 feet down to the water, and the boulder was only 4 inches below its surface. He has use of part of the muscles in one shoulder (otherwise a quadriplegic). This would really help him. He isn't that old. Problem though: he was a dare devil before his accident. He wouldn't think twice of jumping into a Chevy truck with a 350 V8 engine, and hammer on the gas on an icy winter road, then stomp his foot

The adaptability of the nerve network in the human body really does amaze me. I'm glad to see that we're (as in humanity) making some steps toward resolving paralysis. The concept of being trapped in my own body has always been somewhat chilling to me.